FDA.report

CAD/CAM Frame & Partial Denture Co Cr

Primary DI
06975031821068
Brand
CAD/CAM Frame & Partial Denture Co Cr
Company
Beijing Yingguan Dental Technology Co., Ltd.
Model
/
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NSKDentures, Partial

Product Code Classifications

CodeDeviceSpecialtyClass
NSKDentures, PartialUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975031821068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06975031821068069750318210686975031821068

GMDN Terms

TermDefinition
Partial dentureA custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).

Sterilization Methods

Method
Ozone;Ultraviolet Light

Regulatory Flags

DUNS number
560456141
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06975031820016Cast Crown Ni-Cr (NP)/2022-09-30
06975031820023Cast Crown Co Cr (NP)/2022-09-30
06975031820030Cast Crown Pure Tianium/2022-09-30
06975031820047Cast Crown Noble Metal/2022-09-30
06975031820054PFM Crown Ni-Cr (NP)/2022-09-30
06975031820061PFM Crown Co Cr (NP)/2022-09-30
06975031820078PFM Crown Pure Titanium/2022-09-30
06975031820085PFM Crown Noble Metal/2022-09-30
06975031820092Cast Pontic Ni-Cr/2022-09-30
06975031820108Cast Pontic Co Cr/2022-09-30
06975031820115Cast Pontic Pure Titanium/2022-09-30
06975031820122Cast Pontic Noble Metal/2022-09-30
06975031820139PFM Pontic Ni-Cr/2022-09-30
06975031820146PFM Pontic Co Cr/2022-09-30
06975031820153PFM Pontic Pure Titanium/2022-09-30
06975031820160PFM Pontic Noble Metal/2022-09-30
06975031820177Fused Resin Pontic Ni-Cr/2022-09-30
06975031820184Fused Resin Pontic Co Cr/2022-09-30
06975031820191Fused Resin Pontic Pure Titanium/2022-09-30
06975031820207Fused Resin Pontic Noble Metal/2022-09-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810126380173Finish Denture - 1-3 TeethDigital Dental Laboratories, IncNSK2026-02-25
00810126380180Finish Denture - 4-7 TeethDigital Dental Laboratories, IncNSK2026-02-25
00810126380197Finish Denture - 8+ teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380203Flipper - 1 to 2 teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380210Flipper - 3+ teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380227CastingDigital Dental Laboratories, IncNSK2026-02-25
00810126380234Set Denture - 1-3 teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380241Set Denture - 4-7 teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380258Set Denture - 8+ teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380265Unilateral Denture Teeth IncludedDigital Dental Laboratories, IncNSK2026-02-25
00810126380272Acetal unilateralDigital Dental Laboratories, IncNSK2026-02-25
00810126380289Framework acetalDigital Dental Laboratories, IncNSK2026-02-25
00810126380296Framework castDigital Dental Laboratories, IncNSK2026-02-25
00810126380302Unilateral castingDigital Dental Laboratories, IncNSK2026-02-25
00810126380319Unilateral dentureDigital Dental Laboratories, IncNSK2026-02-25
00810126380326Custom trayDigital Dental Laboratories, IncNSK2026-02-25
06977512700053DTS, DENTURES, PARTIALDTS Digital Dental LabNSK2024-06-13
06977512700077DTS, DENTURES, PARTIALDTS Digital Dental LabNSK2024-06-13
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